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Pharmaceutical Technology REGULATORY SOURCEBOOK DECEMBER 2019 35 revision was previously evaluated at the proposal stage, a re-evaluation is performed by SMEs or responsible groups to identify changes that may have been introduced from the proposal to the official publication. Any changes from proposal to official are taken into account to adjust the implementation plan that was developed at the proposal stage; changes from proposal to official are also documented in the change control process to properly implement the official revision. The work then progresses to execution of the implementation plan, thereby providing compliance with the updated official pharmacopoeial requirements. If the pharmacopoeia revision was not previously evaluated when it was proposed, this is the first time a company will identify the update, and all the steps of the impact assessment detailed earlier in the process must be accomplished in the six-month timeframe typically allowed between publication of the new edition or supplement and the official date. The evaluation must now focus on what has changed from the previous of ficial requirements, including how these are reflected in the company's documentation, to the newly updated of f icial requirements. Failure to accomplish all this activity on time, including any laboratory evaluation or data-mining, culminating in the completion of change control, results in a potential compliance gap for the company, which may be revealed upon inspec tion by regulator y agencies. A change control process is challenging at best but is a critical part of the compendial process to ensure compliance with current pharmacopoeia requirements. The change control process ensures input f rom impac ted stakeholder s, including the qualit y and regulatory groups, which is especially important when the change will impact multiple sites, multiple products, and potentially hundreds of product registrations around the world. The timing necessary to submit registration updates and receive any needed approvals from the health authorities, potentially over a time horizon of many years, must be considered and managed properly during this interim period. Although the functional organization and details of the overall surveillance process may vary from one company to the next, there are common elements among the approaches that are ef fective: having multiple SMEs assist in the assessment; starting at the proposal stage; providing responses to the pharmacopoeia; and planning for implementation of updated requirements. Even in the best compendial affairs programs, there are occasions when a company may have difficulty complying with some of the specific, updated official pharmacopoeial requirements. To address this situation, the last step of the industry process, when needed, is for a company to submit a request for revision to the pharmacopoeia authority, advocating for further revision of the general chapter or monograph that was just made official. This request may not be received favorably by the pharmacopoeia if the company did not provide any comments when the revision was first proposed. Similar considerations as those for developing a company's response to a proposal also inform the development of a request for revision to an official update, complete with scientific rationale and data needed to support the requested change. This input from a company starts the entire pharmacopoeia revision process from the top, which again triggers the industry surveillance process. As noted before, pharmacopoeias continually evolve and given all the different viewpoints of the impacted stakeholders in a company, one can begin to get an appreciation of the challenges and complexity faced by all. Reference 1. J. M. Wiggins and J.A. Albanese, "Why Pharmacopoeia Compliance Is Difficult," Pharmaceutical Technology Regulatory Sourcebook eBook, 36-42 (September 2019). Bio/pharmaceutical industry surveillance of compendial changes: Process in detail (cont.) ing process. This is a time-consuming and people-intensive process step, but it may be the only approach to ensure all materials are captured for a company, in the absence of a single, integrated business system. Another important de- termination is which general chapters need to be assessed by a company. Investing the time to develop a grid of "simi- lar" chapters across the pharmacopoeias and which general chapters are used by the company will ensure a robust filter and reduce the number of items that require further assess- ment. Typically, a spreadsheet can be used to establish this matrix of general chapters across pharmacopoeias, with an indicator if the chapter is applicable to the company. The list requires periodic follow up to add new general chapters and remove others that have been made obsolete. Communication tools are also important for a successful surveillance program, to provide the findings of the ongoing pharmacopoeia filtering process throughout the company and enable assessment for potential impact. This includes communication of individual items and an overview report sent at a regular frequency (per publication, monthly, or quarterly). Microsoft Word programs and Microsoft Excel spreadsheets are the typical tools used for such reports. The compendial affairs function needs to keep up-to-date lists of SMEs and other stakeholders for email distribution of necessary reports or task assignments. Having a dedicated email box for the compendial affairs function is also a rec- ommended best practice for communication. This alleviates individuals in the company from having to know a specific person in the compendial affairs role and allows for people changing their roles and responsibilities. Most people can remember a well-named email address (e.g., Compendial- support@company.com) more easily than a specific individ- ual's name. This generic email address allows all members of the compendial function to monitor requests and questions that may be sent to them from any group in the company. If a company's compendial affairs function submits re- sponses to pharmacopoeia proposals, then a process for this needs to be defined. Typically, responses are submitted on company letterhead and sent via email to the pharmaco- Contin. from page 29